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Model Number FOL0102 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that the hitch of the clamp was separating from the adhesive when removing from leg.Per sample received on (b)(6) 2023, the customer returned two used devices.Per additional information received via sample form on (b)(6) 2023, customer stated that this type unit had failed several times causing the catheter to separate itself from the bag at the attach point.Device was replaced.Customer stated that upon inspection of each failed device they all have failed for the same reason, it did not appear that the glue type or application procedure was working out in attaching the statlock swivel unit to the cloth adhesive base.Customer shower each morning with unit attached, using soap and water on the bag and exposed portion of the catheter.
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Manufacturer Narrative
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The reported event is confirmed - cause unknown.It is unknown how the clamp was disconnected from base.Visual inspection noted one (1) used statlock device with open packaging.The potential root cause could be incorrect conveyor setup.The clamp was disconnected from base.Therefore, product does not meet specification.Unable to perform a dhr review since the lot number was not provided.Based on the investigation results, and no additional action is required at this time.A labeling review is not required because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that the hitch of the clamp was separating from the adhesive when removing from leg.Per sample received on 08may2023, the customer returned two used devices.Per additional information received via sample form on 08may2023, customer stated that this type unit had failed several times causing the catheter to separate itself from the bag at the attach point.Device was replaced.Customer stated that upon inspection of each failed device they all have failed for the same reason, it did not appear that the glue type or application procedure was working out in attaching the statlock swivel unit to the cloth adhesive base.Customer shower each morning with unit attached, using soap and water on the bag and exposed portion of the catheter.
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Search Alerts/Recalls
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